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FDA Approves Genentech’s Vabysmo

The first bispecific antibody for the eye to treat two leading causes of vision loss.

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By: Kristin Brooks

Managing Editor, Contract Pharma

Genentech, a member of the Roche Group, received approval from that the U.S. FDA for Vabysmo (faricimab-svoa) for the treatment of wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME). Wet AMD and DME are two leading causes of vision loss among U.S. adults. Vabysmo targets and inhibits two disease pathways linked to a number of vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A).
 
Vabysmo is the first and only FDA-approved injectable eye medicine for wet AMD and DME that improves and maintains vision with treatments from one to four months apart in the first year following four initial monthly doses, based on evaluation of the patient’s anatomy and vision outcomes. Standard of care for wet AMD and DME typically requires eye injections every one to two months.
 
The approval is based on positive results across four Phase III studies in wet AMD and DME. The studies consistently showed that patients treated with Vabysmo given at intervals of up to four months achieved non-inferior vision gains versus aflibercept given every two months in the first year. Vabysmo was generally well tolerated in all four studies, with a favorable benefit-risk profile. The most common adverse reaction (≥5%) reported in patients receiving Vabysmo was conjunctival hemorrhage (7%).
 
Vabysmo is designed to block pathways involving Ang-2 and VEGF-A. Ang-2 and VEGF-A are thought to contribute to vision loss by destabilizing blood vessels, which may cause new leaky blood vessels to form and increase inflammation. While additional research continues, inhibition of both pathways has been shown in preclinical studies to have potentially complementary benefits, stabilizing vessels and thereby reducing vessel leakage and inflammation.

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